Apotex Inc Urgent recruitment for Executive, Quality Assuranc-APRL-QAIP AR-Apply Now

Job Summary

• Responsible for reserve sample activity.
• Responsible for documentation activity
• Responsible for release/rejection of in process, semifinished and finished product batches in SAP
• Responsible for coordinating with customer for batch release

Job Responsibilities

• Planning and co-ordination for reserve sample management activity.
• Loading of Finished product, Raw Material and primary packaging material reserve samples.
• Annual Visual inspection of Finished products.
• Verification of report for batches due for retention completion against batch list and destruction for the same.
• Daily Monitoring reserve sample area temperature and monthly preparing mean kinetic temperature (MKT) report
• Review of samples in reserve sample area and issuances of samples to other departments.
• To be responsible for all activities in the Quality Assurance, including cGMP, documentation and implementation of departmental quality systems.
• Documentation control: Issuance, Archival, retrieval and updation of documentation as per regulatory compliance.
• Preparation of regulatory audits and the compliance for the same.
• Preparation, review and approval of standard operating procedures.
• To Initiate various documents like change controls, standard operating procedures.
• To provide, execute and impart training to QA colleagues with respect to procedure review and updation.
• Responsible for release/rejection of in process, semi-finished batches in SAP.
• Responsible for approving certificate of manufacture (COM) and commercial finished products batch releases/reject to the US/CDN/EU/AUS and other regulatory market.
• Coordinating for customer queries and providing supporting document for batch release activity at the customer end
• Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee’s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees.
• Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally, seeking feedback and development.
• Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values -Collaboration, Courage, Perseverance and Passion.
• Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
• Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures.